의료기기 안전성 정보 안내(의약품흡수유도피부자극기)

의료기기 안전성 정보 안내(의약품흡수유도피부자극기)

1. 관련 근거: 식품의약품안전처 의료기기안전평가과-6195(2020.11.13.)

2. 미국 식품의약품청(FDA)에서 '미세침의료기기의 사용시 감염 등 위해성 및 사용자 권고사항'을

공지한 바, 이와 관련하여 식품의약품안전처의 '의약품흡수유도피부자극기'에 대한 안전성 정보를

안내드립니다.

3. 아울러, 의료기기 부작용 등 이상사례를 인지하는 경우에는 식품의약품안전처 홈페이지

(https://emed.mfds.go.kr → 보고마당 → 이상사례보고) 또는 유선(의료기기안전평가과:

043-719-5007, 5015)으로 알려주시기 바랍니다.

붙임 1. 해외 안전성 정보관련 권고사항

2020. 11. 12 식품의약품안전처    의료기기안전성 서한 의료기기‘의약품흡수유도피부자극기’에 대한 안전성 정보 알림

□ 정보원
❍ 미국 식품의약품청(FDA), 의료기기 안전성에 대해 공지*
* 출 처 : https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/microneedling-devices
            https://www.fda.gov/regulatory-information/search-fda-guidance-documents/regulato                           ry-considerations-microneedling-products

 

□ 주요 내용
❍ 미국 식품의약품청(FDA), 미세 침 의료기기 사용 시 감염 등 위해성 및 사용 시 권고사항 공지

 

□ 대상 의료기기
❍ 의약품흡수유도피부자극기(2등급)
- 사용목적 : 피부를 자극하여 의약품 등의 흡수를 돕기 위해서 사용되는 바늘이 달린 롤러 등의 기구

 

□ 안전성 정보
❍ 부작용
✔ 건조함, 거친 피부, 피부 당김, 붉어짐, 가려움, 피부 벗겨짐, 불편감, 작열감, 멍, 출혈, 각화
✔ 색소침착의 변화(과다색소침착, 과소색소침착), 얼굴주름, 입술 헤르페스 재활성, 림프절 부음, 감염

❍ 환자 권고사항
✔ 치료 관련하여 예상되는 유익성과 위해성에 대해 의사와 상의할 것
✔ 본 제품 훈련을 받은 의사를 선택할 것. 의사에게는 본 기기 관련 훈련 및 치료경험에 대해 문의할 것
✔ 일회용으로 허가받은 의료기기의 경우 재사용하지 말 것

❍ 의료인 권고사항
✔ 허가받은 의료기기만 사용 할 것
✔ 본 제품의 시술에 대해 충분한 훈련을 받은 의사가 시술 할 것
✔ 시술 전에는 의사는 환자에게 본 제품의 적응증, 금기사항, 부작용 등에 대해 충분히 설명할 것
✔ 본 제품과 관련된 부작용은 제조·수입·판매업체에게 반드시 보고 할 것
✔ 본 제품 관련 합병증 증상 또는 징후가 있을 경우 즉시 치료를 받도록 환자에게 권고할 것
✔ 일회용으로 허가받은 의료기기의 경우 재사용하지 말 것

 

❍ 시술(사용)에 적합하지 않은 경우
✔ 혈액응고 장애나 혈우병과 같은 출혈장애 기왕력이 있을 경우
✔ 와파린, 헤파린, 또는 저용량 아스피린과 같은 항응고제를 복용할 경우
✔ 활성피부감염(세균성, 바이러스성, 진균성 감염 포함)이 있을 경우
✔ 습진, 건선, 백반증, 또는 자가면역질환이 있었거나, 있는 경우
✔ 얼굴에 활성발진(여드름 등)이 있는 경우
✔ 현재 입술 헤르페스가 있는 경우
✔ 치료부위에 출생모반이나 점 또는 광선각화증, 켈로이드 흉터 (또는 켈로이드 흉터 기왕력),

    사마귀가 있는 경우
✔ 임부 또는 수유부
✔ 스테인리스강 또는 국소 마취제에 알레르기아 있거나 이들 제품에 대한 접촉성 피부염기왕력

    이 있는 경우
✔ 시술 후 2주 이내 태닝이나 햇빛에 노출되는 일정이 있는 경우

 

                                                                문 의 처                                                     
(의료기기 안전성서한) 식약처 홈페이지(www.mfds.go.kr)

                 정책정보 > 위해정보 > 의료기기위해정보  > 의료기기 안전성서한
(담당부서) 식품의약품안전처 의료기기안전평가과

                 전화 : 043-719-5005 팩스 : 043-719-5000
(부작용 보고)한국의료기기안전정보원(www.nids.or.kr)/의료기기 전자민원창구(http://emed.mfds.go.kr)
                  전화 : 02-860-4421~23 팩스 : 02-860-4379 /전화 : 043-719-5008 팩스 : 043-719-5000

 

 

2. 미국 FDA의 안전성 정보(원문)

Microneedling Devices
The FDA has reviewed and legally authorized specific microneedling products as medical devices for

usein specific areas of the body.
On this page:
-What are Microneedling Devices?
-Legally Marketed Uses of Microneedling Devices
-Risks of Using Microneedling Devices
-Information for Patients About Microneedling Devices
-Information for Health Care Providers About Microneedling Devices

------------------------------

What Are Microneedling Devices?
Microneedling devices are instruments withtechnological features, such as many smallneedles, tips, or pins on the surface, which arerepeatedly inserted and removed into the skin.For example, the needles may be attached to acylinder that is rolled across the skin, projectfrom a flat surface that is "stamped" on theskin, or arranged in a pattern on the tip of apen-shaped instrument.
Microneedling devices create many smallpuncture holes in the skin by moving over theskin repeatedly. Some microneedling devices are manual, meaning the needles always project from thesurface, and they enter the skin when the device is rolled or stamped on the surface. Other devices use amotor to move needles in and out of the device surface. In some motorized devices, the health carepractitioner can adjust and control the depth and speed of penetration of needles into the skin.

--------------------------------

Legally Marketed Uses of Microneedling Devices
The FDA has legally authorized microneedling devices to improve the appearance of facial acne scars,facial wrinkles, and abdominal scars in patients aged 22 years or older. This means the FDA hasreviewed data to support a reasonable assurance of the safety and effectiveness of these devices forthese uses.
Summary documents for De Novos which have been granted or 510(k)s which have been clearedare publicly available on FDA's website. To view these De Novo Decision Summaries or 510(k)Summaries, please check the following databases:

---De Novo database
(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm)
and search forspecific devices or De Novos in the General and Plastic Surgery Panel
---510(k) database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm)
and search for specific devices or the product code, QAI
--To date, the FDA has only granted marketing authorization for a limited number of medicaldevices for specific uses in specified areas of the face and body. The FDA may not have reviewedthe use of certain microneedling devices for all locations in the body. The public summary linksabove specify the intended areas of the face and body for each legally-marketed microneedlingdevice.

Some microneedling products may not be medical devices. For example, generally, microneedlingproducts that do not penetrate into the living skin layers (epidermis and dermis) and claim only to dothe following would not be devices:
--Facilitate exfoliation of the skin (that is, disruption or removal of the stratum corneum)
--Improve the appearance of skin
--Give skin a smoother look and feel
--Give skin a luminous look

 

For additional information regarding whether a microneedling product meets the definition of amedical device and how microneedling devices are regulated, see the FDA's guidance
RegulatoryConsiderations for Microneedling Products (/regulatory-information/search-fda-guidancedocuments/
regulatory-considerations-microneedling-products)
.----------------------------------------------------------

Risks of Using Microneedling Devices
As with any medical procedure, there are risks involved with the use of microneedling devices. That iswhy it is important for you to understand their limits and possible risks.
Any microneedling device has the potential to cause side effects that last a short time or a long time.Some side effects may be permanent. However, most side effects associated with microneedling occurshortly after a treatment and resolve. Microneedling procedures may not always result in the desiredaesthetic outcome.
The following risks are associated with FDA-authorized uses of microneedling devices.
Common risks include:
--Dryness
--Rough skin
--Tightness
--Redness
--Itching
--Peeling

--Discomfort
--Burning
--Bruising
--Bleeding
--Crusting
Less common risks include:
--Pigmentation changes (increase in pigment (hyperpigmentation) or loss of pigment(hypopigmentation)
--Lines on the face
--Reactivation of herpes cold sores
--Swollen lymph nodes
--Infection
--Stinging or itching when cosmetic products are applied

The risks associated with other uses ("off label uses") of microneedling devices, the combination ofmicroneedling devices with other products, or the use of microneedling products that have not beenevaluated by the FDA are not known.

 

Information for Patients About Microneedling Devices
If you are considering a microneedling procedure, the FDA recommends that you:
--Talk to your health care provider regarding the anticipated benefits and risks associated withtreatment.
--Select a health care provider who is trained to perform microneedling procedures. Ask your healthcare provider about his or her training and experience with microneedling.
--Be aware that microneedling may be considered a medical procedure, not a cosmetic procedure,when it meets the definition of a medical device, for example, if intended to change the structureor function of tissue. There are also risks, which are listed above. Microneedling devices are notapproved for delivery of cosmetics, topical medications (for example, creams, ointments, gels),vitamin solutions, drugs, or blood products (for example, platelet-rich plasma (PRP)) into theskin.
--Be aware that you may need more than one procedure to get the desired aesthetic improvement.
--Ask your health care provider how the device is cleaned between patients.
--Ask your health care provider whether a new microneedle cartridge is used for each patient, andfor each treatment session for the same patient. Re-use of the needle cartridge is unsafe and is notconsistent with the FDA's review and authorization, even if the cartridge is cleaned.
--Ask for patient labeling which is available with FDA-authorized microneedling devices.

The procedure may NOT be suitable for you if you:
--Have a known history of clotting or bleeding disorders such as hemophilia.

--Are immune deficient or immune suppressed due to medical conditions or medications.
--Suffer from uncontrolled diabetes (high blood sugar).
--Take anticoagulant (blood thinner) therapies such as warfarin,heparin, or low dose aspirin.
--Suffer from an active skin infection, including bacterial, viral, or fungal infection.
--Suffer from an infection such as hepatitis or human immunodeficiency virus (HIV).
--Have or had eczema, psoriasis, vitiligo, or auto-immune disease.
--Have an active rash on the face.
--Have a current outbreak of cold sores (herpes).
--Are currently taking acne medication with the ingredient isotretinoin (Accutane) or have takenisotretinoin in the past 6 months.
--Have actinic (solar) keratoses, keloid scars (or a history of keloid scars), warts, , or birthmarks ormoles in the treatment area.
--Have darker skin type, as there is a risk of darkening or lightening of the skin after the procedure.Some of the devices authorized for marketing by the FDA were not studied in subjects with darkerskin types.
--Are tan or planning to be in the sun in the two weeks following the procedure.
--Suffer from a known malignancy or are undergoing or about to undergo treatments usingchemotherapy, radiotherapy, or steroids.
--Are pregnant or breastfeeding.
--Are allergic to stainless steel or to topical or local anesthetics or have a history of contactdermatitis to these products.

 

Information for Health Care Providers About MicroneedlingDevices
--Use only FDA-authorized microneedling devices. The FDA urges health care providers to inspectall microneedling packages for authenticity and check if the microneedling device that you havepurchased is listed in the FDA's
De Novo database
(https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm)
or
510(k) PremarketNotification database (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm)
.
--The FDA is aware of several microneedling devices that are not legally marketed. The safety andeffectiveness of these devices has not been reviewed by the FDA.
--Do not use microneedling devices if you do not have the appropriate training or experience.
--Follow all instructions regarding the cleaning and disinfection of microneedling devices.
--Do not reuse a microneedling cartridge or use a microneedling cartridge on more than one patientas this could cause transfer of infectious agents.
--Consider use of prophylactic antivirals in patients with a history of herpes simplex.
--Know the signs and symptoms of complications associated with microneedling devices and havean updated plan detailing how the patient will be treated should this occur. This may include on-site treatment and/or immediate referral to another health care provider for treatment.
--Tell patients that they should seek immediate medical attention if they experience signs orsymptoms of complications associated with microneedling devices.
--Educate facility staff and employees on how to assist patients calling with signs and symptoms ofcomplications related to microneedling devices and on how to receive appropriate medical care.
--Report to the FDA (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?
action=reporting.home)
and the manufacturer if you become aware of any serious adverse eventassociated with the use of microneedling devices, including infection, cross-contamination, anddevice malfunctions.
--Consider that there are many alternative treatments to a microneedling device, including lasers,other energy-based devices, chemical peels, and dermal fillers. Discuss the benefits and risks ofeach treatment option with patients.